FDA discusses the CMC requirements for oncolytic viral products; including considerations for early phase product development, control of starting materials and reagents, manufacturing processes, and product testing.
Presenter:
Bo Liang, Ph.D., Gene Therapy Reviewer, Division of Cellular & Gene Therapies, Office of Tissues and Advanced Therapies (OTAT), CBER
Learn more at: www.fda.gov/dr...
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14 апр 2021
